DRA (Drug Regulatory Affair) Assistant Manager

9 hours ago

Gurgaon, Haryana, India Bal Pharma Full time ₹ 4,00,000 - ₹ 12,00,000 per year

Roles and Responsibilities (5 days working)

  • Dossier (CTD, ACTD & Country Specific Format) review for Latam, ASEAN, CIS & African countries.
  • Collaborate with various departments within the organization, such as Plant (QA, QC, Production, Packing & Purchase) and R&D, to gather the necessary inputs for regulatory submissions.
  • Compilation and timely submission of Dossiers to the respective regulatory authorities in the assigned countries. Planning, monitoring, review, strategy & delegation of the below mentioned activities for Countries:
  • New Product Registration, Re-Registration, Retention, Tender.
  • Handling of queries from various regulatory authorities/consultants.
  • Post Approval Changes
  • GMP (Countries) application
  • Responsible for conducting gap analyses, updating master data, reviewing change controls,

process validations, and artworks.

  • To review administrative, artworks, non-clinical documents.
  • To maintain the regulatory database & status.

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